A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate

NCT ID: NCT03014336

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2025-06-30

Brief Summary

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The drawbacks of chemical CO2 absorbers include the production of compounds harmful to patients that also lead into increased cost and environmental impact, as well as the daily disposal of compound special waste. Sustainable management of general anesthesia is a growing concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are serious environmental problems.

Detailed Description

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DMF Medical has developed a next-generation CO2 filter in order to address the safety issues with current chemical CO2 absorbers in anesthesia.

memsorb uses patented advanced medical membrane technology to filter CO2 from anesthetic circuits rather than absorbing via a chemical reaction.

This game changing technology relies on a polymeric membrane core (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the anesthetic vapor in the circuit.

memsorb is a cartridge similar in size and shape to current solutions that simply clicks in place.

Conditions

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Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

memsorb

Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.

Group Type EXPERIMENTAL

memsorb

Intervention Type DEVICE

memsorb is a CO2 filter replacing current chemical CO2 absorbers

Interventions

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memsorb

memsorb is a CO2 filter replacing current chemical CO2 absorbers

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists Physical Status Class I, II, III (low-medium risk patient)
* English-speaking patients

Exclusion Criteria

* Self-reported as pregnant
* American Society of Anesthesiologists Physical Status Class IV (high risk patient)
* Patients scheduled for emergency surgery
* Documented respiratory disease, including COPD and severe asthma
* Documented elevated pressure in the brain (intra cranial pressure, ICP)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DMF Medical Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orlando Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

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Queen Elizabeth II HSC, Halifax Infirmary Site

Halifax, Nova Scotia, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status COMPLETED

Countries

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Canada

Central Contacts

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Katy Scurman

Role: CONTACT

(902) 221-0451

Vera Lloyd

Role: CONTACT

(902) 225-3893

Facility Contacts

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Orlando Hung, MD

Role: primary

(902)473-7736

Other Identifiers

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DMF-CLIN-16-01

Identifier Type: -

Identifier Source: org_study_id

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